Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study

on behalf of the MACUSTAR consortium

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Abstract

Background: 

Recruiting asymptomatic participants with early disease stages into studies is challenging and only little is known about facilitators and barriers to screening and recruitment of study participants. Thus we assessed factors associated with screening rates in the MACUSTAR study, a multi-centre, low-interventional cohort study of early stages of age-related macular degeneration (AMD).

Methods: 

Screening rates per clinical site and per week were compiled and applicable recruitment factors were assigned to respective time periods. A generalized linear mixed-effects model including the most relevant recruitment factors identified via in-depth interviews with study personnel was fitted to the screening data. Only participants with intermediate AMD were considered.

 Results: 

A total of 766 individual screenings within 87 weeks were available for analysis. The mean screening rate was 0.6 ± 0.9 screenings per week among all sites. The participation at investigator teleconferences (relative risk increase 1.466, 95% CI [1.018–2.112]), public holidays (relative risk decrease 0.466, 95% CI [0.367–0.591]) and reaching 80% of the site’s recruitment target (relative risk decrease 0.699, 95% CI [0.367–0.591]) were associated with the number of screenings at an individual site level. 

Conclusions: 

Careful planning of screening activities is necessary when recruiting early disease stages in multi-centre observational or low-interventional studies. Conducting teleconferences with local investigators can increase screening rates. When planning recruitment, seasonal and saturation effects at clinical site level need to be taken into account. 

Original languageEnglish
Article number54
Number of pages8
JournalBMC Medical Research Methodology
Volume21
DOIs
Publication statusPublished - 17 Mar 2021

Bibliographical note

Funding Information:
All institutional ethic committees approved the study and participants gave written informed consent prior to participation. The MACUSTAR project receives funding from the European Union Innovative Medicines Initiative (IMI2) Horizon 2020 programme. It has been registered at the website clinicaltrials.gov with the identifier NCT03349801. Inclusion criteria for this analysis were individuals screened for the MACUSTAR study with the screening diagnosis intermediate AMD, a high-risk type of the early AMD stages (determined at the clinical site). Study inclusion at all study sites was based on the evaluation and confirmation of AMD diagnosis by a central reading centre, as described previously []. Exclusion criteria were missing informed consent, participation in any of the other MACUSTAR study groups (early, or late AMD or control group) or relocation to another clinical site within the time of the study. The MACUSTAR clinical study is managed by the academic clinical research organization AIBILI (Association for Innovation and Biomedical Research on Light and Image, www.aibili.pt ) and monitored by the European distributed infrastructure network ECRIN-ERIC ( www.ecrin.org ).

Funding Information:
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116076. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Open Access funding enabled and organized by Projekt DEAL.

Publisher Copyright:
© 2021, The Author(s).

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

Keywords

  • Age-related macular degeneration
  • Cohort study
  • Early disease stages
  • Recruitment
  • Screening

ASJC Scopus subject areas

  • Epidemiology
  • Health Informatics

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